Job Title : Quality Compliance Coordinator
Reports to : Site Quality Compliance Manager
location : Cairo, Egypt
Affiliate / Department / Location
Position summary : describe in one or two sentences the primary purpose of the job
Ensure that GMP standards, as they apply to the individual products and the site, are in compliance with Pfizer standards.
Ensure that appropriate systems are in place to meet or exceed the requirements of the company, ISO and the regulatory authorities for the quality of the products manufactured on site.
Responsible for Cleaning validation and External Supplier audits.
Job Description and tasks :
Share in the preparation for and escorting of quality-related audits conducted by Corporate and regulatory agencies.
Draft responses to audit observations.
Review Test Notes (Certificate of Analysis) for MOH.
Interface with MOH inspector to discuss lot records, manufacturing procedures, test results, and labeling.
Managing Supplier external audit program by setting Annual Plan, follow up its execution, reporting and action completion.
Participate in Site Self Audit program as a lead auditor.
Oversee regulatory commitments and Health Authority queries.
Managing & Execution of Cleaning validation plans through developing of relevant validation master plans and SOPs and Reviewing of validation protocols and reports.
Assessing emerging regulatory expectations and impact of inspections at other sites.
Site inspection readiness.
Quality Systems (e.g. oversight of CAS reports and PQS implementation).
Change control review to ensure that proposed changes are complying with PQS requirements.
Develop Data Integrity Plan and deployment of the plan per committed timelines.
Ensure Compliance of Data integrity within Quality System through Periodic Review of Manufacturing and Laboratory operations.
Should perform unannounced data integrity surveillance audits.
Should participate in the investigation and corrective action for reported improper practice.
Evaluate applicable corrective and preventive action (CAPA) responses to the assessment findings for adequacy and timelines.
Provide feedback to management on periodic basis in relation to overall compliance on data integrity.
Shall give awareness training on reported observations, share industry insights.
Responsibility for implementation of Data integrity program in the relevant work area and Insure following up ALCOA principles all over operations.
Active implementation of Notification to Management procedures.
Responsibility for compliance with Pfizer Quality Standards.
Experience and Knowledge
Bachelor's degree in science / pharmaceutical sciences.
Minimum 2 years of experience in quality assurance or compliance department.
Essential Personal Qualifications
Good command of English both written and spoken.
Knowledgeable with interpersonal learning.
Good Communication skills.
High Precision and Accuracy.
Decision making skills.
High analytical skills.
Six Sigma (Green / Black belt) is a plus.
Knowledgeable of Pfizer / regulatory quality Standards
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
Quality Assurance and Control